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Standard Operating Procedure For Product Mock Recalls

This standard operating procedure outlines the steps for conducting a mock product recall test at a pharmaceutical company. The mock recall involves selecting a finished product and lot for recall, assembling relevant production and shipping records, conducting a physical inventory, verifying contact lists are up to date, calculating the percentage of product accounted for, and documenting the results. The goals are to test the recall procedures, identify any issues, and improve efficiency for an actual recall if needed.

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3K views

Standard Operating Procedure For Product Mock Recalls

This standard operating procedure outlines the steps for conducting a mock product recall test at a pharmaceutical company. The mock recall involves selecting a finished product and lot for recall, assembling relevant production and shipping records, conducting a physical inventory, verifying contact lists are up to date, calculating the percentage of product accounted for, and documenting the results. The goals are to test the recall procedures, identify any issues, and improve efficiency for an actual recall if needed.

Uploaded by

Solomon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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SOP Number:QA-xxx

Title: Standard Operating Procedure for Product Mock Recalls

1.Purpose
The purpose of this SOP is to test /challenge the recall procedure of the company.
2.Scope
This SOP is applied toSh. Co. during mock recall exercise.

3.Validity
This SOP is valid up to the next revision date and only if it bears the control seal.

4.Responsibility
The QA manager is responsible for full implementation of the procedure.
5.Materials and Equipment:None
6. Procedure
6.1 The QA manager will pick a recall scenario describing a concern with a specific lot of finished product.
6.2 . Follow Recall Procedure (OP/EPHARM/10/012)
6.3 . The recall team will assemble all records and photocopy relevant records based on the lot codes
shipping of the finished product. Records are stored throughout the facility and will take time to
collect. Do not write on or use highlighters on original records. Use the forms to collect necessary
information during the mock recall exercise.
6.4 . Complete a physical inspection to determine if the identified lot code of finished product is in storage.
6.5 . Verify that the Customer/regulatory body/Recall team list is up-to-date.
Note: Regulatory body and customers will not be notified during a mock recall.
6.6 . Calculate percentage of product accounted for. If the mock recall was not able to account for 100% of the
affected product or took more than 48 hours to complete:
a. Identify the reasons on the mock recall record
b. Implement corrective actions
c. Repeat the mock recall
6.7. Include what went well during the mock recall and what didn’t go well, e.g. identify areas of improvement to
increase efficiency. Document this in the deviation section of the Mock Recall Exercise record.
6.8. Complete the Mock Recall Exercise Record detailing specifics such as material description, lot codes and quantities
6.9. File copies of all related records used during mock recall with Mock Recall Exercise Record (e.g.
Shipping Records, Production Records, etc.) in the QA office.
Note: The Recall Team will participate in a Mock Recall Exercise once a year.
7. Reporting
 Mock Recall record
 The mock recall team will prepare a report regarding the progress of the mock recall including the
reconciliation between the delivered and recovered quantities to the QA Manager.
8. Reference Documents: WHO GMP Guide line

Company Name:

የኢትዮጵያ መድኃኒት ፋብሪካ አ·ማ·


Ethiopian Pharmaceuticals Manufacturing Sh. Co.
Document No: Title: Issue No. Page No.
OF/EPHARM/10/xxx Mock Recall record Form 1 Page x of x

Date :

Start time : Completion time: Total time to complete exercise:


If the mock recall took more than 48 hours to complete:
a. Identify the reasons on the mock recall record (Deviations)
b. Document and Implement corrective actions
c. Repeat the mock recall
Mock Recall Exercise Participants
Name Role Signature

Mock Recall Exercise Scenario


Scenario Description: Finished Product
Name of recalled product(s) :
Lot Number:
Reason for recall:

Finished Product Inventory


Finished Production Batch/lot number Quantity produced
Product date
shipped In storage Damaged(if any)

Total
Finished Product Shipped
Finished Product Date Batch/lot number Shipped to Quantity shipped

Shipping Records matches amount confirmed to have been received by customers (Yes/No):
Effectiveness of Mock Recall Exercise (Recovery) : % of product accounted for
If the mock recall was not able to account for 100% of the affected product:
a. Identify the reasons on the mock recall record (Deviations)
b. Document and Implement corrective actions
c. Repeat the mock recall

Percentage of finished product reconciliation (Cases):

Inventory + Hold due to damage (if any)+ Shipped + Samples


—————————————————————————X 100 = 100%
Total finished product produced
The following lists are confirmed to be up-to-date:
Customer (Yes/No):

Regulatory body (Yes/No):

Recall team (Yes/No):

*Note that regulatory body and customers will not be notified during a mock recall.

Deviations (if any):

Corrective Actions:

What went well:

Mock Recall Exercise Completion:

Name & Signature of Team Leader: ________________ __________ Date: ________________

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